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FDA 510(k)

AcuPebble Ox (200)

K-Number: K243092 · 2025-03-19

ApplicantAcurable Limited
Decision Date2025-03-19
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AcuPebble Ox (200) is a medical device manufactured by Acurable Limited. It received FDA 510(k) clearance on 2025-03-19 under approval number K243092. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AcuPebble Ox (200)?

AcuPebble Ox (200) is a medical device that received FDA 510(k) clearance on 2025-03-19. It is manufactured by Acurable Limited. The 510(k) number is K243092.

When was AcuPebble Ox (200) approved by the FDA?

AcuPebble Ox (200) received FDA 510(k) clearance on 2025-03-19, under approval number K243092.

What company makes AcuPebble Ox (200)?

AcuPebble Ox (200) is manufactured by Acurable Limited.

What is the FDA product code for AcuPebble Ox (200)?

The FDA product code for AcuPebble Ox (200) is MNR.

Other Devices by Acurable Limited

K210480AcuPebble SA K222950AcuPebble OX100

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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